https://www.selleckchem.com/pr....oducts/vafidemstat.h
In August 2020, the International Council on Harmonisation (ICH) released a new draft document, which for the first time combined nonclinical (S7 and clinical (E14) Questions and Answers (QAs) into 1 document. FDA describes the revision as a "value proposition" if the human ether-à-go-go assay and the in vivo study are performed in a standardized way, the number of dedicated thorough QT (TQT) studies can be reduced. In this article, we describe and discuss the QAs that relate to clinical ECG evaluation. If supported by n
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